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Novel Imaging Modalities For Plexiform Neurofibromas


N/A
N/A
25 Years
Open (Enrolling)
Both
Neurofibromatosis Type 1, Precancerous Condition

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Trial Information

Novel Imaging Modalities For Plexiform Neurofibromas


OBJECTIVES:

- Determine whether fludeoxyglucose F 18 positron emission tomography (FDG-PET) and MR
perfusion studies can predict plexiform neurofibroma growth rates in patients with
neurofibromatosis 1.

- Determine whether FDG-PET and MR perfusion studies can predict the likelihood of
response in patients who are undergoing investigational treatment for plexiform
neurofibromas.

- Identify neuroimaging characteristics that distinguish patients who have responded to
therapy from those who have not after completion of treatment.

OUTLINE:

- Stratum 1: Patients undergo MR perfusion scan with gadopentetate dimeglumine and
fludeoxyglucose F 18 positron emission tomography (FDG-PET) at baseline and
quantitative MRI evaluation at baseline and 1 year.

- Stratum 2: Patients undergo quantitative MRI, MR perfusion scan with gadopentetate
dimeglumine, and FDG-PET at baseline and 1 year.

PROJECTED ACCRUAL: A total of 48 patients (32 for stratum 1 and 16 for stratum 2) will be
accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Stratum 1:

- Diagnosis of neurofibromatosis 1 (NF1) and plexiform neurofibromas

- At high risk for progression, as defined by any of the following:

- Anatomic location such that progression carries a high risk of impairment
of function, pain, or disfigurement (e.g., neck/mediastinum, paraspinal
nerve roots, orbit, and face)

- Tumors that the patient, family, or caregiver believes have increased in
size within the past year, but appear stable by standard clinical or
radiographic measures

- No plexiform neurofibromas that are small, cause no pain or functional
impairment, or are not likely to cause pain or functional impairment over the
succeeding 12 months

- Stratum 2:

- Diagnosis of NF1 and progressive plexiform neurofibromas

- Neurofibroma progression documented by increase in lesion size on MRI

- Currently being enrolled on a clinical therapeutic trial at Children's Hospital
of Philadelphia

PATIENT CHARACTERISTICS:

Age

- 25 and under

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant or nursing

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Stratum 1:

- No prior or concurrent chemotherapy

- No concurrent enrollment on a chemotherapy clinical trial

- Stratum 2:

- At least 4 weeks since prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- At least 6 weeks since prior radiotherapy (stratum 2)

Surgery

- Prior surgery for progressive plexiform neurofibroma allowed if incompletely resected
and measurable disease remains (stratum 2)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Tumor progression as measured by tumor area and volume at 1 year

Safety Issue:

No

Principal Investigator

Michael Fisher, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital of Philadelphia

Authority:

Unspecified

Study ID:

CDR0000299006

NCT ID:

NCT00060008

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Neurofibromatosis Type 1
  • Precancerous Condition
  • neurofibromatosis type 1
  • plexiform neurofibroma
  • Neurofibroma
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Osteitis Fibrosa Cystica
  • Precancerous Conditions
  • Neurofibroma, Plexiform

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283